Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
ID03560388

Assessing Effectiveness of Acupuncture and Integrative Care in Reducing Peri- and Intra-operative Pain and Anxiety in Patients With Gynecological Cancer: A Randomized Controlled Study

Led by Carmel Medical Center · Updated on 2024-08-21

135

Participants Needed

1

Research Sites

14 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Patients undergoing surgery for gynecological cancer often experience high levels of anxiety before the operation due to uncertainties about their diagnosis, treatment, and outlook. After surgery, pain and quality of life concerns can worsen emotional distress and symptoms. This research aims to explore how complementary and integrative medicine (CIM) treatments, including acupuncture, might affect anxiety, pain, and overall quality of life in these patients. The study involves three groups: one receiving standard supportive care without additional treatments, one receiving touch and relaxation therapy before surgery, and one receiving both pre-operative touch and relaxation therapy along with acupuncture during surgery. The CIM program is provided within 24 hours before and during the surgical procedure to assess its impact. Participants will be assessed for changes in pain and anxiety from one hour before surgery to 24 hours after surgery. Researchers will also monitor the use of pain medications during surgery and the first day after. The study includes questionnaires and evaluations to measure quality of life and symptom changes. The total participation period covers the surgery and 24 hours following it, with safety and treatment effects monitored during this time.

CONDITIONS

Brief Title

Acupuncture and Integrative Care in Gynecological Surgery

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 18 years or older
  • Referred for surgery for suspected or confirmed gynecological oncology cancer at Carmel Medical Center
  • Classified as class 1 to 3 peri-operative risk by American Society of Anesthesia
Not Eligible

You will not qualify if you...

  • Unwilling to sign the research participation form or unable to understand the consent
  • Pregnant at the time of the study
  • Chronic pain patients treated with opioids within one month before surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Approximately 4 to 6 hours during surgery and 24 hours post-surgery

Participants receive integrative care treatments including pre-operative touch-relaxation and intra-operative acupuncture during their gynecological surgery to reduce pain and anxiety.

1 pre-operative visit and intra-operative treatment with 24-hour post-operative monitoring

Trial Site Locations

Total: 1 location

1

Carmel Medical center

Haifa, Israel, 35152

Actively Recruiting

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Research Team

E

Eran Ben-Arye, MD

O

Ofer Lavi, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

3

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